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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K953414
Device Name CPR MICROMASK WITH OXYGEN INLET
Applicant
Plasco, Inc.
4080 Morrison Dr.
Gurnee,  IL  60031
Applicant Contact GARY S BOTSFORD
Correspondent
Plasco, Inc.
4080 Morrison Dr.
Gurnee,  IL  60031
Correspondent Contact GARY S BOTSFORD
Regulation Number868.5870
Classification Product Code
CBP  
Date Received07/20/1995
Decision Date 03/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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